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Under the rulemaking procedures for a product standard, FDA would need to be far more precise in defining the standard, allowing applicants to make informed judgments about the likelihood of success and to avoid over-specifying expensive trials when the success criteria are unknown

Two landmark studies published last week in the Journal of the American Medical Association demolish one of the canons in cardiology -- that half of all heart attacks result from genetics, as opposed to health-related risk factors

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